Randomised trial comparing a Low Carbohydrate Diet and a Low Glycaemic Index Diet on body weight, hyperandrogenism and cardiovascular risk factors in women with Polycystic Ovary Syndrome (PCOS)
| ISRCTN | ISRCTN55425758 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55425758 |
| Secondary identifying numbers | N0199129935 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 06/04/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Mohgah Elsheikh
Scientific
Scientific
Centre for Diabetes & Endocrinology
Melrose House
Royal Berkshire Hospital
London Road
Reading
RG1 5AN
United Kingdom
| Phone | +44 (0)118 987 7131 |
|---|---|
| mohgah.elsheikh@rbbh-tr.nhs.uk |
Study information
| Study design | Randomised case-controlled prospective study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | Does a low carbohydrate high protein diet enhance weight loss and improve symptoms in women with polycystic ovary syndrome (PCOS)? Assessment of the effects of the low carbohydrate diet on serum androgens and cardiovascular risk factors such as insulin sensitivity and plasma lipids. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Nutritional, Metabolic, Endocrine: Polycystic ovarian syndrome (PCOS) |
| Intervention | Low Carbohydrate Diet vs Low Glycaemic Index Diet |
| Intervention type | Other |
| Primary outcome measure | Weight, body composition, dietary compliance, menstrual cyclicity, ovulation, fasting glucose, insulin and lipids, hirsutism and serum androgens |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 30/07/2003 |
| Completion date | 30/04/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 45 Years |
| Sex | Female |
| Target number of participants | 60 |
| Key inclusion criteria | 60 women with PCOS aged 18-45 |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 30/07/2003 |
| Date of final enrolment | 30/04/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Centre for Diabetes & Endocrinology
Reading
RG1 5AN
United Kingdom
RG1 5AN
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Government
Royal Berkshire and Battle Hospitals NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Abstract results | results published | No | No |
